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Sponsors routinely collect vast arrays of non-serious adverse events (AEs), extensive lab investigations, and physical assessments, even in settings where the drugs safety profile is already well-characterized

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(2012) observed a significant reduction in plasma ApoM levels among patients with varying degrees of sepsis, septic shock, and SIRS compared to healthy controls, with the extent of reduction reflecting the severity of SIRS/sepsis

Contract development and manufacturing organizations themselves are a distinct, fast-growing customer set as they sub-contract specialized steps such as large-scale lyophilization or in-line quality-control testing

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